Date: 2014-11-03
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the International Meeting on Emerging Diseases and Surveillance (IMED) in Vienna
Company: Mologen (Germany) and the LEISHDNAVAX consortium
Product: MGN1331 - DNA vaccine against leishmaniasis
Action
mechanism: The DNA vaccine MGN1331 consists of a combination of MIDGE® vectors encoding different Leishmania antigens. The MIDGE® technology developed by MOLOGEN (MIDGE® stands for Minimalistic Immunologically Defined Gene Expression) is also termed a DNA vector. However, unlike other DNA vectors (plasmids, viruses), the MIDGE® vector contains only the information necessary for the actual effect. In animal models, promising efficacy and a very good safety profile of MGN1331 has been shown.
Disease: leishmaniasis
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On November 3, 2014, the LEISHDNAVAX consortium, with the biotechnology company MOLOGEN AG as a key partner, presented preclinical data of the leishmaniasis vaccine (MGN1331) in a poster at the International Meeting on Emerging Diseases and Surveillance (IMED) in Vienna. Data on the immunogenicity and prophylactic efficacy of the DNA-based leishmaniasis vaccine was shown.The abstract "Multiantigen T cell epitope-enriched leishmaniasis vaccine" (22.149) indicates that the vaccine proved immunogenic and protective in a mouse model of visceral leishmaniasis. GLP studies with single and multiple vaccinations revealed a good safety profile of the vaccine and the vaccine is ready to be tested in clinical trials. * On June 26, 2012, the LEISHDNAVAX consortium, with MOLOGEN AG as a key partner, has successfully concluded the preclinical development of a MIDGE®-based vaccine against leishmaniasis (MGN1331). Within the framework of the project, the new human vaccine has been examined as to its efficacy and safety in animal models, for prophylactic as well as therapeutic applications. The independent panel of experts that reviewed the results within the framework of a final project symposium confirmed the very promising results. Reviewer Prof. Dr. N.K. Ganguly, former director of the Indian Council of Medical Research and expert in immunology of tropical diseases, said in this regard: "The preclinical data presented by the consortium are decidedly promising. In particular, the applicability to the prevention of this dangerous disease means immense progress in the fight against leishmaniasis." As one step of the preclinical development, first scientific meetings with the European Medicines Agency (EMA) and the Paul-Ehrlich Institute have taken place already, so that the planning of phase I clinical studies can begin now. Possibilities for further subsidies are currently explored. Another product candidate is also ready to enter the clinical study phase. The project was supported by the European Union to the amount of € 3 million as part of the Seventh Framework Program. The LEISHDNAVAX consortium members are Mologen (Germany), the London School of Hygiene & Tropical Medicine (LSHTM - UK), Charité - Universitätsmedizin Berlin (Charite - Germany), Indian Institute of Chemical Biology (IICB), Kolkata (India), Institut Pasteur de Tunis (IPT - Tunisia), Hebrew University of Jerusalem (HUJI) (Israel), Rajendra Memorial Research Institute of Medical Sciences (RMRI-MS) (India) and Drugs for Neglected Diseases Initiative (DNDi).
